Full Press Release Details
Therapeutics Reports First Quarter 2021 Financial Results
FRANCISCO, May 6, 2021 -- Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for the first quarter
ended March 31, 2021.
and investments in marketable securities at March 31, 2021 were approximately $1.1 billion as compared to $1.2 billion at December
continue to build momentum with our clinical pipeline of novel cytokine therapeutics," said Howard W. Robin, President
and CEO of Nektar. "We have a robust development program for bempegaldesleukin focused on pursuing large front-line and adjuvant
tumor settings. Our five registrational studies underway in melanoma, renal cell carcinoma, and bladder cancer are progressing as planned.
In February, we added a sixth registrational study for bempegaldesleukin plus pembrolizumab in head and neck cancer, which we expect
to initiate later this year. In addition, we remain on track to report the first data for our PROPEL study evaluating bempegaldesleukin
plus pembrolizumab in patients with metastatic non-small cell lung cancer in the second half of 2021."
our second cytokine program in oncology, NKTR-255, our initial efforts include two Phase 1 clinical studies in combination with ADCC
antibodies, one in hematological malignancies and one in solid tumors, and we look forward to sharing data from these studies in Q4
of this year," continued Mr. Robin. "Finally, as part of the broad development program for NKTR-358, our T regulatory
cell IL-2 agent, our partner Eli Lilly is conducting Phase 2 studies in both lupus and ulcerative colitis and plans to initiate
additional Phase 2 studies in two different immune-mediated diseases over the next 9-12 months."
of Financial Results
in the first quarter of 2021 was $23.6 million as compared to $50.6 million in the first quarter of 2020. The decrease
was due primarily to the recognition of the $25.0 million milestone payment from Bristol-Myers Squibb related to the initiation of the
registrational trial of bempegaldesleukin plus Opdivo in muscle-invasive bladder cancer in the first quarter of
operating costs and expenses in the first quarter of 2021 were $133.0 million as compared to $184.2 million in the first quarter
of 2020. Operating costs and expenses decreased primarily as a result of $45.2 million in impairment charges in the first quarter
of 2020 resulting from the discontinuation of the NKTR-181 program and a decrease in R&D expense.
expense in the first quarter of 2021 was $95.6 million as compared to $109.0 million for the first quarter of 2020. R&D
expense decreased primarily due to a decrease in manufacturing costs for bempegaldesleukin.
expense was $31.7 million in the first quarter of 2021 and $26.2 million in the first quarter of 2020. G&A expense increased
primarily due to an increase in pre-commercial costs for bempegaldesleukin.
loss for the first quarter of 2021 was $123.0 million or $0.68 basic and diluted loss per share as compared to a net loss of $138.7
million or $0.78 basic and diluted loss per share in the first quarter of 2020.
Quarter 2021 and Recent Business Highlights:
Call to Discuss First Quarter 2021 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Thursday,
press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and
Investors section of the Nektar website: https://ir.nektar.com/. The web broadcast of the conference
call will be available for replay through June 6, 2021.
access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (International)
Conference ID: 9233368 (Nektar Therapeutics is the host)
the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained
on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after
the conclusion of the conference call.
Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology,
and virology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional
operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities
may be found online at http://www.nektar.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "may," "design,"
"potential," "plan," "expect," "project" and similar references to future periods. Examples
of forward-looking statements include, among others, statements we make regarding the therapeutic potential of, and future development
plans for, bempegaldesleukin, NKTR-358 and NKTR-255, and the timing of the initiation of clinical studies for our drug candidates. Forward-looking
statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations
and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes
in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially
from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important
factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among
others: (i) our statements regarding the therapeutic potential of bempegaldesleukin, NKTR-358 and NKTR-255 are based on preclinical
and clinical findings and observations and are subject to change as research and development continue; (ii) bempegaldesleukin, NKTR-358
and NKTR-255 are investigational agents and continued research and development for these drug candidates is subject to substantial risks,
including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings in earlier preclinical
and clinical studies); (iii) bempegaldesleukin, NKTR-358 and NKTR-255 are in various stages of clinical development and the risk of failure
is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical
trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient
enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes,
competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) patents may
not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual
property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our Annual
Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2021. Any forward-looking statement made by us
in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake
no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result
of new information, future developments or otherwise.
Wu of Nektar Therapeutics
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value)
| March 31, 2021 | December 31, 2020 (1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 150,164 | $ | 198,955 | ||||
| Short-term investments | 887,152 | 862,941 | ||||||
| Accounts receivable | 29,156 | 38,889 | ||||||
| Inventory | 16,808 | 15,292 | ||||||
| Other current assets | 15,771 | 21,928 | ||||||
| Total current assets | 1,099,051 | 1,138,005 | ||||||
| Long-term investments | 96,093 | 136,662 | ||||||
| Property, plant and equipment, net | 58,510 | 59,662 | ||||||
| Operating lease right-of-use assets | 124,971 | 126,476 | ||||||
| Goodwill | 76,501 | 76,501 | ||||||
| Other assets | 1,435 | 1,461 | ||||||
| Total assets | $ | 1,456,561 | $ | 1,538,767 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 22,434 | 22,139 | ||||||
| Accrued compensation | 23,513 | 14,532 | ||||||
| Accrued clinical trial expenses | 41,028 | 44,207 | ||||||
| Accrued contract manufacturing expenses | 6,057 | 11,310 | ||||||
| Other accrued expenses | 14,833 | 9,676 | ||||||
| Operating lease liabilities, current portion | 15,768 | 13,915 | ||||||
| Total current liabilities | 123,633 | 115,779 | ||||||
| Operating lease liabilities, less current portion | 134,556 | 136,373 | ||||||
| Development derivative liability | 4,597 | - | ||||||
| Liabilities related to the sales of future royalties, net | 195,139 | 200,340 | ||||||
| Other long-term liabilities | 4,130 | 8,980 | ||||||
| Total liabilities | 462,055 | 461,472 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 18 | 18 | ||||||
| Capital in excess of par value | 3,429,734 | 3,388,730 | ||||||
| Accumulated other comprehensive loss | (3,121 | ) | (2,295 | ) | ||||
| Accumulated deficit | (2,432,125 | ) | (2,309,158 | ) | ||||
| Total stockholders' equity | 994,506 | 1,077,295 | ||||||
| Total liabilities and stockholders' equity | $ | 1,456,561 | $ | 1,538,767 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share information)
| Three months ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Revenue: | ||||||||
| Product sales | $ | 4,795 | $ | 3,444 | ||||
| Royalty revenue | - | 9,719 | ||||||
| Non-cash royalty revenue related to sale of future royalties | 18,798 | 9,895 | ||||||
| License, collaboration and other revenue | 54 | 27,515 | ||||||
| Total revenue | 23,647 | 50,573 | ||||||
| Operating costs and expenses: | ||||||||
| Cost of goods sold | 5,756 | 3,811 | ||||||
| Research and development | 95,604 | 108,987 | ||||||
| General and administrative | 31,679 | 26,217 | ||||||
| Impairment of assets and other costs for terminated program | - | 45,189 | ||||||
| Total operating costs and expenses | 133,039 | 184,204 | ||||||
| Loss from operations | (109,392 | ) | (133,631 | ) | ||||
| Non-operating income (expense): | ||||||||
| Non-cash interest expense on liability related to sale of future royalties | (13,296 | ) | (6,968 | ) | ||||
| Change in fair value of development derivative liability | (1,599 | ) | - | |||||
| Interest income and other income (expense), net | 1,412 | 8,352 | ||||||
| Interest expense | - | (6,204 | ) | |||||
| Total non-operating income (expense), net | (13,483 | ) | (4,820 | ) | ||||
| Loss before provision for income taxes | (122,875 | ) | (138,451 | ) | ||||
| Provision for income taxes | 92 | 200 | ||||||
| Net loss | $ | (122,967 | ) | $ | (138,651 | ) | ||
| Basic and diluted net loss per share | $ | (0.68 | ) | $ | (0.78 | ) | ||
| Weighted average shares outstanding used in computing basic and diluted net loss per share | 181,370 | 177,185 |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| Three months ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (122,967 | ) | $ | (138,651 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Non-cash royalty revenue related to sale of future royalties | (18,798 | ) | (9,895 | ) | ||||
| Non-cash interest expense on liability related to sale of future royalties | 13,296 | 6,968 | ||||||
| Change in fair value of development derivative liability | 1,599 | - | ||||||
| Non-cash research and development expense | 2,248 | - | ||||||
| Stock-based compensation | 23,898 | 25,236 | ||||||
| Depreciation and amortization | 3,543 | 4,502 | ||||||
| Impairment of advance payments to contract manufacturers and equipment for terminated program | - | 20,351 | ||||||
| Amortization of premiums (discounts), net and other non-cash transactions | 2,345 | (1,289 | ) | |||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | 9,733 | (5,229 | ) | |||||
| Inventory | (1,516 | ) | (1,655 | ) | ||||
| Operating leases, net | 1,541 | 2,940 | ||||||
| Other assets | 6,183 | 1,067 | ||||||
| Accounts payable | 779 | 2,687 | ||||||
| Accrued compensation | 8,981 | 9,920 | ||||||
| Other accrued expenses | (7,345 | ) | 7,483 | |||||
| Deferred revenue | (605 | ) | (2,510 | ) | ||||
| Net cash used in operating activities | (77,085 | ) | (78,075 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchases of investments | (295,314 | ) | (241,068 | ) | ||||
| Maturities of investments | 303,612 | 439,735 | ||||||
| Sales of investments | 5,036 | - | ||||||
| Purchases of property, plant and equipment | (2,876 | ) | (900 | ) | ||||
| Net cash provided by investing activities | 10,458 | 197,767 | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from shares issued under equity compensation plans | 17,106 | 11,077 | ||||||
| Cash receipts from development derivative liability | 750 | - | ||||||
| Net cash provided by financing activities | 17,856 | 11,077 | ||||||
| Effect of foreign exchange rates on cash and cash equivalents | (20 | ) | (97 | ) | ||||
| Net increase (decrease) in cash and cash equivalents | (48,791 | ) | 130,672 | |||||
| Cash and cash equivalents at beginning of period | 198,955 | 96,363 | ||||||
| Cash and cash equivalents at end of period | $ | 150,164 | $ | 227,035 | ||||
| Supplemental disclosures of cash flow information: | ||||||||
| Cash paid for interest | $ | - | $ | 4,951 | ||||
| Operating lease right-of-use asset recognized in exchange for lease liabilities | $ | 1,057 | $ | 2,133 |